Actelion announces first quarter 2009 financial results

Corporate news announcement processed and transmitted by Hugin AS.
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announcement.
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Total net revenues of CHF 405.6 million, up 26 percent compared to Q1
2008 - Tracleer® sales of CHF 352.2 million, up 24 percent in local
currencies - Cash EBIT of CHF 146.5 million - PAH franchise
strengthened with novel thermostable i.v. epoprostenol - US launch in
preparation

ALLSCHWIL/BASEL, SWITZERLAND - 21 April 2009 - Actelion Ltd (SIX:
ATLN) today announced its financial results for the first quarter of
2009. With total net revenues for the first three months of 2009 of
CHF 405.6 million (Q1 2008: CHF 321.6 m) and operating expenses of
CHF 284.0 million (Q1 2008: CHF 253.8 m), the company reported an
operating profit of CHF 121.6 million (Q1 2008: CHF 67.8 m).

To better measure and compare operating performance over time,
Actelion continues to report non-US GAAP Cash EBIT (Operating Income
excluding charges such as In-Process R&D, charges related to employee
stock options under FAS 123R as well as non-cash depreciation and
amortization charges). For the first three months of 2009, Actelion
achieved a Cash EBIT of CHF 146.5 million, an increase of 60 percent
compared to the same period in 2008. In local currencies, Cash EBIT
increased by 63 percent. Adjusted (non-US GAAP) diluted earnings per
share for the first quarter of 2009 were CHF 1.05, compared to CHF
0.57 in the first quarter of 2008.

On a US GAAP basis, net profit for the first quarter 2009 was CHF
102.1 million (Q1 2008: CHF 44.5 m). Starting on 1 January 2009, due
to the adoption of FSP APB 14-1, the company incurred total non-cash
charges of CHF 4.5 million related to its 2006 convertible bond. The
comparative periods have been adjusted.

Fully diluted earnings per share (EPS), on a US GAAP basis, for the
first three months of 2009 were CHF 0.83, compared to CHF 0.36 for
the same period in 2008.

Jean-Paul Clozel, M.D. and Chief Executive Officer commented: "I am
pleased to report a strong performance of Actelion in the first
quarter of this year. We demonstrate again our ability to
successfully grow our products in the market place, grow
profitability today and advance our pre-clinical and clinical
pipeline for further profitable growth tomorrow."

Jean-Paul Clozel concluded: "Actelion's success is the result of our
focus on innovation in all we do, from the lab bench to the sales
call. I am looking forward to share with you study results of our
Phase III programs with bosentan in IPF and clazosentan in aSAH once
they become available in the second half of 2009. Given our ability
to execute on a global scale, positive results could lead to
continued and rapidly accelerating growth"

Andrew J. Oakley, Chief Financial Officer commented: "Actelion
continues to deliver significant top-line growth, accompanied by
measured increases in our cost base. We continue to generate free
cash flow and enjoy a strong cash position. From this situation of
strength, we continue to invest into potential future revenue drivers
from our own pipeline, whilst being able to appropriately strengthen
our product range through in-licensing or acquisitions, as
demonstrated in late February through the acquisition of another PAH
agent."

Andrew J. Oakley added: "With a good start into the year, I am able
to confirm previous guidance. Unforeseen events excluded, Actelion
expects 2009 to be another year of growth, with total net revenues -
in local currencies - to increase between 12 and 15 percent. Cash
EBIT is forecasted to increase - in local currencies - by 10 to 12
percent."

Financial result overview - Table Q1 2009 vs. Q1 2008

In CHF thousands Result Q1 Result Q1 Variance %
2009 2008
Net Revenues 405,613 321,576 84,037 26
Operating Expenses 283,982 253,814 30,168 12
Operating Income 121,631 67,762 53,869 79
Cash EBIT 146,539 91,500 55,039 60
Net Income 102,143 44,474* 57,669 130
Diluted EPS in CHF 0.83 0.36 0.47 131
No of shares in 122,647 123,357
calculation

* 2006 convertible bond reclassification according to adoption of FSP
APB 14-1 - comparative period adjusted

The full financial statements can be found on
http://www.actelion.com.

Continued growth of total net revenues
In the first quarter of 2009, Actelion's total net revenues increased
by 26 percent to CHF 405.6 million (Q1 2008: CHF 321.6 m). In local
currencies, total net revenues increased by 27 percent compared to
the first quarter of 2008.

Contract revenues for the first three months of 2009 amounted to CHF
16.2 million (Q1 2008: CHF 6.9 m).

Product sales
During the first quarter of 2009, Tracleer® (bosentan) sales were CHF
352.2 million (Q1 2008: CHF 287.6 m). In local currencies, this
represents an increase of 24 percent compared to the same period last
year.

Following the US Food and Drug Administration complete response
letter regarding the Tracleer® supplemental New Drug Application in
early March 2009, Actelion has responded to all questions raised in
the initial review of the Risk Evaluation and Mitigation System
(REMS). Once REMS has been resolved successfully, the FDA will then
be in a position to finalize their review for inclusion of less
severe, so-called Functional Class II, PAH patients to the US product
label.

At the end of March 2009, Tracleer® was commercially available in
over 50 countries worldwide, including all major pharmaceutical
markets.

At the end of March 2009, the Korean Health Authorities expanded the
product label for Tracleer® to include Functional Class II patients.
In addition, the Korean Health Authorities also approved as a new
indication for Tracleer®, the prevention of Digital Ulcers in
patients suffering from systemic sclerosis. In mid-April 2009, a
similar label expansion and new indication approval was issued by the
Brazilian Health Authorities as well.

Actelion continues to strengthen Tracleer®'s availability with
further market introductions expected in the coming quarters. In the
first three months of 2009, Actelion successfully registered first
sales in several new territories such as Mexico.

Ventavis® (iloprost) sales amounted to CHF 27.0 million in the first
quarter of 2009
(Q1 2008: CHF 17.4 m). This represents an increase of 45 percent in
US Dollar terms.

Otto Schwarz, President Business Operations, commented: "The
outstanding performance of Tracleer® is the result of our continued
commitment to the PAH community in general and, specifically, the
generation and consequent medical communication of important clinical
datasets in multiple patient populations."

In late February 2009, Actelion acquired from privately-held
GeneraMedix Inc. an improved, thermostable formulation of
epoprostenol sodium for the intravenous treatment of pulmonary
arterial hypertension (PAH) which was approved in mid-2008 in the
United States for the long-term intravenous treatment of primary
pulmonary hypertension and pulmonary hypertension associated with the
scleroderma spectrum of disease in NYHA Class III and Class IV
patients who do not respond adequately to conventional therapy.

Otto Schwarz continued: "We are rapidly moving forward with our
efforts to enable US market introduction of this thermostable
formulation of Epoprostenol. Also we plan to initiate regulatory
review for this product outside of the United States in the near
future."

In the first quarter of 2009, Zavesca® (miglustat) sales were CHF
10.3 million (Q1 2008: CHF 9.7 m). In local currencies, Zavesca®
sales increased by 11 percent. Zavesca® is commercially available in
over 35 countries including the United States and most European
markets. At the end of March 2009, the Korean Health Authorities
approved Zavesca® for the treatment of adult patients with mild to
moderate type I Gaucher disease for whom enzyme replacement therapy
is not a therapeutic option.

In January 2009, Zavesca® (miglustat) received approval in the
European Union for the treatment of progressive neurological
manifestations in adult patients and pediatric patients with
Niemann-Pick type C disease (NP-C). Zavesca® is the first treatment
to be approved for patients with Niemann-Pick type C disease, a very
rare and devastating neurodegenerative genetic disorder affecting
both children and adults.

Otto Schwarz concluded: "We are committed to fully explore the
benefits of Zavesca® in patients suffering from Gaucher type-1
disease, first and foremost with the ongoing MAINTENANCE study. In
addition, we will make not only significant efforts to communicate
the use of Zavesca® in NP-C, but we will also work with the medical
community to increase disease awareness of this very rare, and
under-diagnosed genetic disorder."

In the United States, Actelion had a constructive pre-NDA (New Drug
Application) meeting with the FDA and now expects to file a
supplemental NDA for miglustat (Zavesca®) in
NP-C in the coming months.

Operating expenses
During the first quarter of 2009, operating expenses were CHF 284.0
million (Q1 2008: CHF 253.8 m).

During the same period, research and development expenses increased
by 2 percent to CHF 95.8 million (Q1 2008: CHF 93.9 m). Q1 2008
operating expenses include a milestone payment related to the PGI2
receptor agonist in-licensed from Nippon Shinyaku. Excluding this
payment, R&D expenses increased by 12 percent year on year.

Actelion gave a comprehensive description of its research and
development pipeline in February at the Actelion Day 2009 event. A
replay of this event is available from the investor events section of
the corporate website - www.actelion.com.

Actelion's pipeline now has 9 compounds in clinical development as
well as more than 25 active projects in drug discovery. The four
ongoing Phase III programs include almorexant in primary insomnia
(first Phase III results by year-end 2009, additional clinical
studies under SPA discussion with US Food and Drug Administration),
bosentan in idiopathic pulmonary fibrosis IPF (final study results
before year-end 2009) clazosentan for non-traumatic subarachnoid
hemorrhage (Phase III results by year-end 2009) and macitentan in PAH
(Phase III results in late 2012).

The clinical programs are progressing as outlined at this event with
the following update:

Miglustat in Cystic Fibrosis: The proof-of-concept study with
miglustat in cystic fibrosis has concluded and Actelion is currently
analyzing study results.

Renin Inhibitor: Based on the results of several clinical studies,
the renin alliance with Merck & Co., Inc. (through an affiliate), has
decided to discontinue the clinical development of the Phase I
clinical candidate. The alliance will continue to assess other renin
inhibitors currently in the drug discovery phase.

Selling, general and administrative expenses for the first three
months of 2009 amounted to CHF 138.8 million (Q1 2008: CHF 121.0 m),
an increase of 15 percent.

Creation of Chief Scientific Officer (CSO) position

To further strengthen the medical perspective throughout Actelion's
discovery process and to provide additional scientific input in the
development process, Martine Clozel, MD and Co-Head of Drug
Discovery, has been nominated by the Board of Directors to
additionally take on the newly created role of Chief Scientific
Officer (CSO).

Operating profit
Actelion's operating profit for the first quarter of 2009 was CHF
121.6 million (Q1 2008: CHF 67.8 m). Cash EBIT for the same period
amounted to CHF 146.5 million (Q1 2008: CHF 91.5 m).

Net Profit
In the first quarter of 2009, the net profit of CHF 102.1 million (Q1
2008: CHF 44.5 m) includes interest income of CHF 1.5 million,
interest expense of CHF 0.3 million, non-cash interest and
amortization charges on the Convertible Bond of CHF 4.5 million,
foreign currency losses of CHF 5.4 million and an income tax expense
of CHF 10.8 million.

Cash and cash flow
During the first quarter of 2009, Actelion generated net cash flow
from operations of CHF 27.8 million (Q1 2008: CHF 22.1 m). As at 31
March 2009 total liquid funds (excluding 7.8 million treasury shares)
amounted to CHF 1.1 billion.

For documentation purposes - table Q1 2009 vs. Q4 2008

In CHF thousands Result Result Variance %
Q1 2009 Q4 2008
Net revenues 405,613 403,888 1,725 0
Operating Expenses 283,982 307,727 (23,745) (8)
- Research and 95,848 96,939 (1,091) (1)
Development
- Selling, General and 138,831 162,368 (23,537) (14)
Admin.
Operating Income 121,631 96,161 25,470 26
Cash EBIT 146,539 121,190 25,349 21
Net Income 102,143 82,621 19,522 24
Diluted EPS in CHF 0.83 0.67 0.16 24
No of shares in 122,647 123,377
calculation

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Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate
headquarters in Allschwil/Basel, Switzerland. Actelion's first drug
Tracleer®, an orally available dual endothelin receptor antagonist,
has been approved as a therapy for pulmonary arterial hypertension.
Actelion markets Tracleer® through its own subsidiaries in key
markets worldwide, including the United States (based in South San
Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in
innovative science related to the endothelium - the single layer of
cells separating every blood vessel from the blood stream. Actelion's
over 2000 employees focus on the discovery, development and marketing
of innovative drugs for significant unmet medical needs. Actelion
shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as
part of the Swiss blue-chip index SMI (Swiss Market Index SMI® )

For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com

Conference Call
Actelion will host an Investor Conference Call / Webcast as follows:

Date/Time:

21 April 2009 15.30 hrs - 16.45 hrs Basel (CEST)
14.30 hrs - 15.45 hrs U.K. (BST)
09.30 a.m. - 10.45 a.m. U.S. (EDT)

Conference Call Connect #:
Dial-in participants should start calling the number below 10-15
minutes before the Conference is due to start.

Dial: Europe: +41 44 580 65 22
U.K.: +44 207 108 62 06
U.S.: +1 866 895 85 61

Participant's mode:
Listen-Only with possibility to open individual lines during Q&A
session. Participants will be asked for their Name and Company.

Webcast Access:
Webcast participants should visit the Actelion website for further
details http://www.actelion.com/
10-15 minutes before the conference is due to start. If you
experience any access problems go directly to the URL:
http://gaia.world-television.com/actelion/20090421/trunc

Webcast Replay:
The archived Investor Webcast will be available for replay through
http://www.actelion.com/ approximately 60 minutes after the call has
ended.

Upcoming Corporate Events

Friday, 24 April, 2009 -AGM 2009
Tuesday, 21 July, 2009 -H1 Results 2009
Tuesday, 20 October, 2009 -Q3 Results 2009
Thursday, 18 February, 2010 - Full Year Results 2009

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil
Switzerland

WKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP,
SMIM, SPI, SPIEX;
Listed: Main Market in SIX Swiss Exchange;
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